Surpass, Inc. is a preclinical contract research organization in the greater Twin Cities area, near the medical device cluster around Minneapolis and St. Paul. It describes itself as "a trusted partner and contract research organization (CRO) specializing in preclinical services for medical devices, drugs, pharmaceuticals, biologics, and combination products,"[S1] and states that its team "has successfully serviced the global Biomedical Community for more than 20 years."[S1] Its work is surgical and interventional: large animal studies and human cadaver studies rather than rodent toxicology. This profile summarizes the services, models, stated compliance information, and company facts most relevant to US sponsors.
Services relevant to US drug and device developers
Surgical and interventional in vivo studies
The company organizes its work around eleven named clinical areas: cardiac covering structural heart and electrophysiology, dermal, gastrointestinal, general and reconstructive surgery, neurological, oncology, orthopedic and spine, respiratory, urogenital, vascular, and wound healing and traumatic injury, plus a track for de novo and disruptive technologies.[S7] It states that "our experience spans everything from early feasibility through GLP safety studies, including assessments of performance, biocompatibility, efficacy, human factors, and more."[S7] Species used are "rabbits, pigs, sheep, calves, dogs, and goats."[S5] Named models on the research page span abdominal compartment syndrome, aneurysm, benign prostatic hyperplasia, cardiopulmonary bypass, cartilage, ligament and tendon injury, cerebral stroke and trauma, chronic total occlusion, congestive heart failure, coronary artery bypass grafting, in-stent restenosis, lung volume reduction, myocardial infarction, organ resection and transplant, sepsis, thrombus and deep vein thrombosis, Vx2 tumor and wound healing.[S5]
Human cadaver studies and bio-skills training
Alongside animal work the company offers human cadaver studies and physician training. It states that it "can also source serologically tested human cadaver models with disease states of interest for your preclinical research studies or bio-skills clinical training,"[S5] including specimens with conditions such as coronary or peripheral artery disease or osteoporosis, or with previously placed devices such as stents, grafts and pacemakers, and can set up vascular flow loops on request.[S5] For device developers this is often where early design feedback is obtained before an animal study is committed.
Pathology and analytical testing are delivered through partners
Histopathology and analytical testing are not performed in house. The company states that it "works with experts in their respective fields to conduct histopathology and analytical testing required for in vivo studies,"[S6] naming external partners for gross pathology, histology processing and drug content analysis.[S11] Analytical work listed includes "drug content testing on devices, blood, tissues and urine."[S6] Sponsors should establish which organization holds the study, which holds the pathology phase, and how the quality system applies across both.
Quality, compliance, and animal welfare (as stated by the company)
GLP with the regulation named. The quality page lists the regulations the company works to: "Good Laboratory Practice (GLP) Regulations 21 CFR Part 58 for Safety Studies," "Animal Welfare Act and Animal Welfare Regulations 9 CFR Parts 1-4," and "Electronic Records 21 CFR Part 11."[S3] On the services side the company states that it has "developed an international reputation as a GLP-compliant lab and the preclinical CRO-of-choice to conduct GLP studies for supporting successful regulatory and clinical submissions"[S4] and cites "hundreds of GLP preclinical studies under our belt, positive FDA inspection results, and technical expertise across numerous medical disciplines."[S4] The inspection claim is the company's own summary with no dates or classifications published; FDA inspects nonclinical laboratories under its Bioresearch Monitoring program but does not approve or certify laboratories.[R6] GLP compliance applies study by study, so sponsors should confirm the scope in the protocol.[R2]
Accreditation and animal welfare. The company states that "Surpass facilities are accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International."[S3] Two points of wording are worth noting. On USDA the site uses "USDA-compliant" for its animal housing[S2] rather than stating that it is a USDA-registered research facility, and no registration number is published. On OLAW it states that it "maintains Office of Laboratory Animal Welfare (OLAW) Assurances on file for National Institutes of Health (NIH)-funded projects,"[S3] which is scoped to NIH-funded work rather than presented as a blanket assurance. The term IACUC was not found on any of the pages reviewed, although the company does state that it "is committed to the ethical treatment and humane care of laboratory animals."[S3] It also states that it "regularly performs Department of Defense (DOD)-funded studies."[S3] AAALAC International accreditation is a voluntary evaluation of an institution's animal care and use program, re-evaluated every three years,[R3] and USDA registration and an OLAW Animal Welfare Assurance relate to the Animal Welfare Act and the PHS Policy respectively;[R4][R5] none of these establishes GLP compliance, which applies to individual studies.[R2] FDA does not approve or certify laboratories; registration with FDA does not denote approval.[R6] This profile does not evaluate the company's animal care program; the statements above are the company's own.
Described as the Midwest, greater Twin Cities area. No street address is published on the website; press releases from 2013 and 2014 carry an Osceola, Wisconsin dateline[S2][S10]
Founded
Not stated; the company cites more than 20 years serving the biomedical community[S1]
Ownership
Private; no investor or stock listing is disclosed[S1]
President and CEO
Tim Pelura, PhD, appointed effective December 16, 2013[S10]
FDA ? "Is It Really FDA Approved?" (FDA does not approve health care providers, including laboratories; registration does not denote approval); FDA Compliance Program 7348.808 (GLP inspections of nonclinical laboratories). https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved (accessed 2026-09-03)
3 Recommended Contract Research Organizations
for Non-Clinical Studies
— by Target goal and Expertise
In non-clinical development, the choice of contract research organization shapes the quality of the data and the time it takes to reach the next decision. Below, three CROs are introduced by the type of study they support: pharmacology (efficacy) studies, safety studies, and pharmacokinetic (PK/PD) studies. Each summary describes the services the company offers so that you can match a provider to your target and development objective.
Pharmacology (Efficacy) StudiesDisease-Relevant Models for Translational Drug Evaluation
Reference: SMC Laboratories, Inc. official website (https://www.smccro-lab.com/)
SMC Laboratories, Inc.
SMC Laboratories is a specialized non-clinical CRO focused on in vivo pharmacology and efficacy studies using disease-relevant animal models, particularly in fibrosis, inflammation, metabolic diseases, and oncology.
Areas of Expertise
Disease-Relevant Model Portfolio
SMC Laboratories offers models covering the liver, lung, kidney, intestine, and oncology. Its portfolio includes the proprietary STAM™ model for MASH, fibrosis, and hepatocellular carcinoma.
Study Design Based on Target Biology
Study plans are developed around the target biology, mechanism of action, disease stage, and development objective. Pharmacological endpoints can be combined with histopathology, biomarkers, and disease-specific readouts.
Support from Target Validation to Proof of Concept
With experience from more than 1,000 studies for clients in 30 countries, SMC Laboratories supports programs from target validation and candidate selection through in vivo proof-of-concept studies.
Safety StudiesComprehensive Safety Assessment for Preclinical Development
Reference: Charles River Laboratories official website (https://www.criver.com/)
Charles River Laboratories
Charles River provides non-clinical toxicology and safety assessment services for programs ranging from exploratory safety studies to IND-enabling development.
Areas of Expertise
General Toxicology Across Study Designs
Services include single- and repeat-dose toxicology, dose-range finding, and general toxicology studies across multiple species and administration routes.
Non-GLP and GLP Study Support
Charles River supports both non-GLP and GLP studies, allowing sponsors to progress from early safety characterization to studies intended for regulatory submissions.
Integrated IND-Enabling Safety Assessment
Toxicology studies can be integrated with toxicokinetics, clinical pathology, histopathology, and safety pharmacology to support interpretation and IND-enabling safety packages.
Pharmacokinetic (PK/PD) StudiesConnecting Drug Exposure with Pharmacological Response
Reference: Inotiv official website (https://www.inotiv.com/)
Inotiv
Inotiv provides integrated PK/PD, DMPK, and bioanalytical services to characterize drug exposure and its relationship with pharmacological response.
Areas of Expertise
Pharmacokinetic Characterization
PK studies characterize exposure, half-life, clearance, and other pharmacokinetic parameters needed to understand how a candidate behaves in the selected model.
Exposure–Response Evaluation
Pharmacokinetic data can be combined with pharmacodynamic endpoints and bioanalysis to evaluate the relationship between drug exposure and pharmacological response.
Integrated DMPK and Development Support
Integrated DMPK, pharmacology, and safety information supports candidate comparison, dose selection, dosing-frequency optimization, and decisions about subsequent preclinical development.
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